Quality Assurance Lead at Verona Pharma

Description

Job DescriptionQuality Assurance - Lead Technician (FPU/FPP Release)<ul><li>Permanent, full-time role with competitive remuneration and benefits</li><li>Location: Wellington - Upper Hutt, New Zealand</li><li>Grow your QA leadership career in a successful, expanding industry</li><li>Lead critical QA activities for FPU/FPP release in a global Animal Health manufacturer</li><li>Be the go-to expert for batch documentation, product release and continuous improvement</li></ul>What You Will DoResponsibilities include, however not limited to:You will play a key role in batch documentation, product release, and quality systems, helping ensure timely supply of high-quality products.Batch Documentation Ensure batch documentation is available and compliant to meet production and testing schedules by:<ul><li>Providing backup for QA / Senior QA Officers in issuing batch documents and test worksheets, allocating expiry dates, and completing SAP transactions</li><li>Monitoring department KPIs and supporting action plans with the Quality Assurance Manager</li></ul>Driving continuous improvement by providing subject matter expertise in QA systems such as:<ul><li>Batch review and disposition</li><li>Document control and archiving</li><li>GMP training systems</li><li>Internal auditing</li><li>Change control and deviation management</li><li>Right First-Time and other quality improvement programs</li></ul>Product Release Support timely and compliant product release by:<ul><li>Providing backup for QA / Senior QA Officers in reviewing batch/test documentation for accuracy, completeness and compliance, and facilitating corrections with other departments</li><li>Performing second quality review of Solution, Antigen, Bulk Antigen and Blend batch records</li><li>Releasing Antigen, Blend and packed product batch records</li><li>Reviewing and approving market documents for export and ensuring release documentation meets export schedules</li><li>Providing batch disposition for temperature excursions</li><li>Approving revalidations of Antigens and Pack-at-Risk</li></ul>General Documentation & Compliance<ul><li>Generate, review and maintain all documentation in line with company and relevant quality standards</li><li>Ensure all production-related batch and inventory records are accurate and complete</li><li>Define processes and drive improvements through updated standards and training</li><li>Follow global and local procedures for reporting Adverse Events and Product Quality Complaints within required timelines</li></ul>Deviations & Change Management<ul><li>Review and approve deviation closures, including supporting documentation</li><li>Use root cause analysis to define appropriate Corrective and Preventative Actions (CAPAs)</li><li>Assess compliance risks for impacted products and recommend product disposition</li><li>Approve events following completed batch disposition</li></ul>What You Must haveEducation<ul><li>Bachelor’s degree or higher in a science-based discipline</li></ul>Certifications<ul><li>Qualified Lead Auditor (desirable)</li></ul>Experience & Skills<ul><li>Strong understanding of QA systems, GLP and GMP requirements in a production environment</li><li>Extensive prior experience in a similar role in a GMP/GLP manufacturing environment, ideally in the pharmaceutical industry within Quality Operations or similar manufacturing role</li><li>Demonstrated experience in more than one biopharmaceutical function (e.g. manufacturing, technology, validation, engineering, quality, analytical)</li><li>Excellent written and verbal communication skills with the ability to positively influence others</li><li>Proven ability to work collaboratively to resolve complex problems</li><li>Demonstrated leadership and ability to build strong relationships and alignment with key stakeholders</li><li>Logical, structured approach to problem solving</li><li>Strong planning and organisational skills, with the ability to meet deadlines</li></ul>What You Can Expect<ul><li>A pivotal QA role where your decisions directly support safe, reliable product supply</li><li>Autonomy to manage your work, with strong support from a trusted, global-leading Animal Health organisation</li><li>Clear opportunities to upskill, cross-train and progress your QA career</li><li>Exposure to quality systems and projects that broaden your technical and leadership capabilities</li><li>A collaborative team of experienced QA and Operations professionals who value knowledge sharing and continuous improvement</li></ul>We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace.Required Skills: Batch Record Review, Batch Releases, Compliance Risk Management, Corrective and Preventive Action (CAPA), Driving Continuous Improvement, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Legal Compliance, Quality Assurance (QA), Quality Process Development, Supplier Quality ManagementPreferred Skills: Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a>Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a>Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:03/21/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Get notified about similar roles

Similar active positions

Quality Assurance Lead

Description

Verona Pharma

Pipeline